Dual Chamber Blanket/Fluid Warmer

FDA UDI

Class I (US FDA UDI)

by Mac Medical, Inc.

Identity

Trade Name: DUAL CHAMBER BLANKET/FLUID WARMER FDA UDI
Generic Name: Blanket warming cabinet, dry-heat FDA UDI
Device Name: Overall size 30”W x 26.5”D x 74.5”T. 17.59 Cubic ft. storage 4 Adjustable shelves. Upper Chamber I.D. 26”W x 23”D x 25”T 8.63 Cubic ft. storage. Temperature Range: 90-160 F Accuracy +/- 2 degrees F Lower chamber I.D. 26 “W x 23”D x 26”T 8.96 Cubic ft. storage. Temperature Range: 90-160 F Accuracy +/- 2 degrees F Digital control. Glass doors. Audible and visual over-temp alarm. Keyed temperature lock for each chamber Data logger Dual upper door lock Mobile Base Electrical: 120V, 12 Amp, 50/60 Hz. 69kw/hr, 2356 btu/hr. UL/CUL listed FDA Registered FDA UDI
Model / Reference: W2630MSTD-G-MB FDA UDI
Description: Overall size 30”W x 26.5”D x 74.5”T. 17.59 Cubic ft. storage 4 Adjustable shelves. Upper Chamber I.D. 26”W x 23”D x 25”T 8.63 Cubic ft. storage. Temperature Range: 90-160 F Accuracy +/- 2 degrees F Lower chamber I.D. 26 “W x 23”D x 26”T 8.96 Cubic ft. storage. Temperature Range: 90-160 F Accuracy +/- 2 degrees F Digital control. Glass doors. Audible and visual over-temp alarm. Keyed temperature lock for each chamber Data logger Dual upper door lock Mobile Base Electrical: 120V, 12 Amp, 50/60 Hz. 69kw/hr, 2356 btu/hr. UL/CUL listed FDA Registered FDA UDI

Identifiers

Catalog Number: W2630MSTD-G-MB FDA UDI
Primary DI / UDI-DI: B286W2630MSTDGMB1 FDA UDI
510(k) Number: K080609 FDA UDI
FDA Product Code: LHC FDA UDI
GMDN Term: Blanket warming cabinet, dry-heat FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.5950 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Blanket warming cabinet, dry-heat

Dual Chamber Blanket/Fluid Warmer by Mac Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blanket warming cabinet, dry-heat.

Cleared under the same submission

K080609 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Mac Medical, Inc.

Sources (1)

FDA UDI 933bd56b-b256-42ea-beae-7028eda6ff11 36 fields · synced Jun 6, 2026